NCT01665066

Brief Summary

The aim of the present study is to compare serum nicotine levels of different e-Cigarette strength with usual cigarettes. Serum levels of carcinogenic and toxic substances will be also compared.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 15, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

December 13, 2012

Status Verified

December 1, 2012

Enrollment Period

5 months

First QC Date

July 23, 2012

Last Update Submit

December 12, 2012

Conditions

Tobacco Abuse Smoke

Outcome Measures

Primary Outcomes (1)

  • nicotine pharmacokinetic

    participants will be cannulated and serial venous blood samples for Nicotine will be collected at 0.5, 2, 5, 15, 30 and 60 min after being instructed to take 10 puffs of cigarette

    0 sec, 30 second, 2 minutes, 5 minutes, 15 minutes, 30 minutes, 60 minutes

Secondary Outcomes (1)

  • Serum levels of carcinogenic and toxic substances (Aldehydes; ROM/TOS; Total thiols)

    0 sec, 30 second, 2 minutes, 5 minutes, 15 minutes, 30 minutes, 60 minutes

Study Arms (5)

Own Brand cigarette

ACTIVE COMPARATOR

Smoke Own Brand cigarette, 15 puff of cigarette.

Other: Own Brand cigaretteOther: one high 2,4% nicotineOther: original 7,4 mg nicotineOther: nicotine freeOther: Ego 9mg

One High 2,4% nicotine

EXPERIMENTAL

Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette.

Other: Own Brand cigaretteOther: one high 2,4% nicotineOther: original 7,4 mg nicotineOther: nicotine freeOther: Ego 9mg

Original 7,4 mg nicotine

EXPERIMENTAL

Smoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette.

Other: Own Brand cigaretteOther: one high 2,4% nicotineOther: original 7,4 mg nicotineOther: nicotine freeOther: Ego 9mg

Nicotine Free

PLACEBO COMPARATOR

Smoke electronic cigarette nicotine free (15 puff)

Other: Own Brand cigaretteOther: one high 2,4% nicotineOther: original 7,4 mg nicotineOther: nicotine freeOther: Ego 9mg

EGO 9mg

EXPERIMENTAL

Smoke electronic cigarette EGO for a day (15 puff)

Other: Own Brand cigaretteOther: one high 2,4% nicotineOther: original 7,4 mg nicotineOther: nicotine freeOther: Ego 9mg

Interventions

Own Brand cigaretteOTHER

Smoke, 15 puff of, Own Brand cigarettes;

EGO 9mgNicotine FreeOne High 2,4% nicotineOriginal 7,4 mg nicotineOwn Brand cigarette
one high 2,4% nicotineOTHER

Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine

Also known as: Categoria electronic cigarette one high 2,4% nicotine
EGO 9mgNicotine FreeOne High 2,4% nicotineOriginal 7,4 mg nicotineOwn Brand cigarette
original 7,4 mg nicotineOTHER

Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine

Also known as: Categoria electronic cigarette 7,4 mg nicotine
EGO 9mgNicotine FreeOne High 2,4% nicotineOriginal 7,4 mg nicotineOwn Brand cigarette
nicotine freeOTHER

smoke, 15 puff, of electronic cigarette nicotine free

Also known as: categoria electronic cigarette nicotine free "mint".
EGO 9mgNicotine FreeOne High 2,4% nicotineOriginal 7,4 mg nicotineOwn Brand cigarette
Ego 9mgOTHER

smoke, 15 puff, of electronic cigarette Ego 9 mg

Also known as: electronic cigarette Ego 9 mg nicotine
EGO 9mgNicotine FreeOne High 2,4% nicotineOriginal 7,4 mg nicotineOwn Brand cigarette

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • regular smokers (smoking ≥ 15 factory-made cigarettes per day for at least the past 10 years and not currently attempting to quit smoking or wishing to do so in the next 30 days, CO \> 10 parts per million ) will be recruited from the local Hospital staff in Catania, Italy.

You may not qualify if:

  • people who reported recent myocardial infarction, angina pectoris or other serious medical conditions (diabetes mellitus, severe allergies, poorly controlled asthma or other airways disease, poorly controlled psychiatric disorders or current chemical dependence other than nicotine) and
  • pregnancy,
  • breastfeeding,
  • blood pressure \> 180 mm Hg systolic and/or 100 mm Hg diastolic,
  • weight \< 45 or \> 120 kg, or
  • current use of any other smoking cessation medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro per la Prevenzione e Cura del Tabagismo

Catania, Catania, 95124, Italy

Location

Related Publications (1)

  • Goniewicz ML, Kuma T, Gawron M, Knysak J, Kosmider L. Nicotine levels in electronic cigarettes. Nicotine Tob Res. 2013 Jan;15(1):158-66. doi: 10.1093/ntr/nts103. Epub 2012 Apr 22.

    PMID: 22529223RESULT

MeSH Terms

Interventions

Nicotine

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Riccardo Polosa, MD, Phd

    University of Catania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine

Study Record Dates

First Submitted

July 23, 2012

First Posted

August 15, 2012

Study Start

May 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 13, 2012

Record last verified: 2012-12

Locations

IT(1)